Prevalence and Clinical Spectrum of the 22q11 Deletion

This study has been terminated.

(sufficient data collected)

Sponsor:

Information provided by:

Children's Healthcare of Atlanta

ClinicalTrials.gov Identifier:

NCT00267397

First received: December 19, 2005

Last updated: May 2, 2007

Last verified: May 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

December 19, 2005

Last Updated Date

May 2, 2007

Start Date ^ICMJE

January 1967

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00267397 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Prevalence and Clinical Spectrum of the 22q11 Deletion

Official Title ^ICMJE

Prevalence and Clincial Spectrum of the 22q11 Deletion: A Population Based Study of Children and Congenital Heart Defects

Brief Summary

The purpose of this project is to conduct population based surveillance for prenatally diagnosed congenital defects amount residents of the five counties to: improve the comprehensiveness of the Metropolitan Atlanta Congenital Defects Program (MACDP) to (1) better fulfill its objectives (2) allow assessment of the impact of prenatal diagnosis and elective termination on the birth prevalence of congenital defects in Atlanta (3) develop a registry of prenatally diagnosed defects to be used in epidemiologic and genetic studies, in evaluation prevention programs and in monitoring prenatal diagnostic technology.

Detailed Description

Since 1967, The Centers for Disease Control and Prevention (CDC) has conducted surveillance of birth defects in metropolitan Atlanta through review of hospital delivery and newborn medical records and records from various other medical sources in the five central counties of the metropolitan area (Clayton, Cobb, DeKalk, Fulton and Gwinnett, and has been expanded to include prenatal records. The project was begun n the aftermath of thalidomide and rubella epidemics as a kind of early-warning system for new or resurgent teratogens. The voluntary participation of Atlanta hospitals was sought and obtained at the inception of the system (the original system was a joint effort of the CDC, the Georgia Institute of Mental Health and Emory University).

A case must be diagnosed by the child's sixth birthday or within six years of the date of elective termination.

Children's Healthcare is one retrospective source of medical records reviewed for discharge summaries and disease indices.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Retrospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition ^ICMJE

Congenital Disorders

Intervention ^ICMJE

Not Provided

Study Groups/Cohorts

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Not Provided

Estimated Completion Date

December 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

birth defect diagnosed by the child's sixth birthday
birth defect diagnosed within 6 years of the elective date of termination

Exclusion Criteria:

those who do not meet inclusion criteria

Sex/Gender

Sexes Eligible for Study:

All

Ages

up to 6 Years (Child)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00267397

Other Study ID Numbers ^ICMJE

01-107

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Children's Healthcare of Atlanta

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Robert M. Campbell, MD

Children's Healthcare of Atlanta

PRS Account

Children's Healthcare of Atlanta

Verification Date

May 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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